Back to resultsEfficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vortioxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major Depressive Disorder, Depression, Melancholia, Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- Suffers from Major Depressive Disorder as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).
- The reported duration of the current major depressive episode is at least 3 months at the Screening Visit.
- Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.
- Has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and Baseline Visits.
Exclusion Criteria:
Has one or more of the following conditions:
- Any current psychiatric disorder other than Major Depressive Disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR; assessed by the Mini International Neuropsychiatric Interview: MINI). A participant who exhibits symptoms of anxiety is eligible unless fulfilling the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
- Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR. Participant with confirmed positive urine drug screens (except prescribed medications or a medication that does not constitute drug abuse) will be excluded.
- Presence or history of a clinically significant neurological disorder (including epilepsy).
- Neurodegenerative disorder. (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.)
- Any DSM-IV-TR axis II disorder that might compromise the study.
- The current depressive symptoms of the participant are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
- Has received electroconvulsive, vagal nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the Screening Visit.
- Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
- Is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
Vortioxetine 5 mg
Vortioxetine 10 mg
Vortioxetine 20 mg
Arm Description
Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate.
Secondary Outcome Measures
Percentage of Participants With a MADRS Response at Week 8
Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.
Percentage of Participants in MADRS Remission at Week 8
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.
Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate.
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01255787
Brief Title
Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
Official Title
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of multiple doses of vortioxetine, once daily (QD), in participants with major depressive disorder.
Detailed Description
The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying doses of vortioxetine.
The study enrolled 600 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
Vortioxetine 5 mg
Vortioxetine 10 mg
Vortioxetine 20 mg
Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.
All participants were asked to take one capsule at the same time each day throughout the study.
This multi-center trial was conducted in 14 countries in Europe and Asia. The overall time to participate in this study was up to 13 weeks. Participants made weekly visits to the clinic during the first 2 weeks of the 8-week treatment period and then every 2 weeks up to the end of the 8-week treatment period. Participants who completed the 8-week treatment period entered a 2-week discontinuation period to assess potential discontinuation symptoms 1 and 2 weeks after the end of the 8-week treatment period. A safety follow-up contact (visit or phone call) was made 4 weeks after completion of the 8-week double-blind treatment period (2 weeks after the end of the 2-week discontinuation period).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Major Depressive Disorder, Depression, Melancholia, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
Arm Title
Vortioxetine 5 mg
Arm Type
Experimental
Arm Description
Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Arm Title
Vortioxetine 10 mg
Arm Type
Experimental
Arm Description
Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
Arm Title
Vortioxetine 20 mg
Arm Type
Experimental
Arm Description
Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Other Intervention Name(s)
Lu AA21004, Brintellix®
Intervention Description
Vortioxetine tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vortioxetine placebo-matching tablets
Primary Outcome Measure Information:
Title
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Description
The MADRS is a depression rating scale consisting of 10 items, each rated 0 (normal) to 6 (most abnormal). The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). A decrease in the total score or on individual items indicates improvement. Least squares (LS) means were from an Analysis of Covariance (ANCOVA) model with treatment as a fixed factor and the Baseline value as a covariate.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants With a MADRS Response at Week 8
Description
Response is defined as a participant with a ≥50% decrease in Montgomery Åsberg Depression Rating Scale (MADRS) total score from Baseline. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.
Time Frame
Baseline and Week 8
Title
Percentage of Participants in MADRS Remission at Week 8
Description
Remission is defined as a participant with a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≤10. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.
Time Frame
Week 8
Title
Mean Clinical Global Impression Scale - Improvement (CGI-I) Score at Week 8
Description
The Clinical Global Impression - Global Improvement scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline Clinical Global Impression-Severity of Illness (CGI-S) score as a covariate.
Time Frame
Week 8
Title
Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 8
Description
The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and family life or home responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment. LS means were from an ANCOVA model with treatment as a fixed factor and the Baseline value as a covariate.
Time Frame
Baseline and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suffers from Major Depressive Disorder as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).
The reported duration of the current major depressive episode is at least 3 months at the Screening Visit.
Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.
Has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and Baseline Visits.
Exclusion Criteria:
Has one or more of the following conditions:
Any current psychiatric disorder other than Major Depressive Disorder as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR; assessed by the Mini International Neuropsychiatric Interview: MINI). A participant who exhibits symptoms of anxiety is eligible unless fulfilling the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR. Participant with confirmed positive urine drug screens (except prescribed medications or a medication that does not constitute drug abuse) will be excluded.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder. (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.)
Any DSM-IV-TR axis II disorder that might compromise the study.
The current depressive symptoms of the participant are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has received electroconvulsive, vagal nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the Screening Visit.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Split
Country
Croatia
City
Zagreb
Country
Croatia
City
Helsinki
Country
Finland
City
Kuopio
Country
Finland
City
Oulu
Country
Finland
City
Tampere
Country
Finland
City
Berlin
Country
Germany
City
Bochum
Country
Germany
City
Chemnitz
Country
Germany
City
Hannover
Country
Germany
City
Leipzig
Country
Germany
City
Munchen
Country
Germany
City
Nuernberg
Country
Germany
City
Schwerin
Country
Germany
City
Westerstede
Country
Germany
City
Wiesbaden
Country
Germany
City
Hong Kong
Country
Hong Kong
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
City
Ahmedabad
State/Province
Gujarat
Country
India
City
Lucknow
State/Province
Uttar Pradesh
Country
India
City
Varanasi
State/Province
Uttar Pradesh
Country
India
City
Kanpur
State/Province
UttarPradesh
Country
India
City
Tokoname-shi
State/Province
Aichi
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Kitakyushu-shi
State/Province
Fukuoka
Country
Japan
City
Omuta-shi
State/Province
Fukuoka
Country
Japan
City
Shirakawa-shi
State/Province
Fukushima
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
City
Tokyo
Country
Japan
City
Sungnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
City
Incheon
State/Province
Korea
Country
Korea, Republic of
City
Seoul
State/Province
Korea
Country
Korea, Republic of
City
Yangsan-si
State/Province
Korea
Country
Korea, Republic of
City
Liepaja
Country
Latvia
City
Riga
Country
Latvia
City
Sigulda
Country
Latvia
City
Johor Bahru
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Makati City
State/Province
NCR
Country
Philippines
City
Mandaluyong City
State/Province
NCR
Country
Philippines
City
Manila
State/Province
NCR
Country
Philippines
City
Quezon City
State/Province
NCR
Country
Philippines
City
Bialystok
Country
Poland
City
Gorlice
Country
Poland
City
Leszno
Country
Poland
City
Torun
Country
Poland
City
Zuromin
Country
Poland
City
Iasi
State/Province
Lasi
Country
Romania
City
Targu Mures
State/Province
Mures
Country
Romania
City
Bucharest
Country
Romania
City
Bucuresti
Country
Romania
City
Ekaterinburg
State/Province
Russia
Country
Russian Federation
City
Nizhny Novgorod
State/Province
Russia
Country
Russian Federation
City
Rostov on Don
State/Province
Russia
Country
Russian Federation
City
Saint-Petersburg
State/Province
Russia
Country
Russian Federation
City
Smolensk
State/Province
Russia
Country
Russian Federation
City
St. Petersburg
State/Province
Russia
Country
Russian Federation
City
Stavropol
State/Province
Russia
Country
Russian Federation
City
Belgrade
Country
Serbia
City
Kragujevac
Country
Serbia
City
Senta
Country
Serbia
City
Changhua
Country
Taiwan
City
Kaohsiung City
Country
Taiwan
City
Taipei City
Country
Taiwan
City
Taipei
Country
Taiwan
City
Taoyuan Hsien
Country
Taiwan
City
Chernigiv region
Country
Ukraine
City
Dnipropetrovsk
Country
Ukraine
City
Kharkiv,
Country
Ukraine
City
Kiev
Country
Ukraine
City
Lugansk
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
28858412
Citation
Nishimura A, Aritomi Y, Sasai K, Kitagawa T, Mahableshwarkar AR. Randomized, double-blind, placebo-controlled 8-week trial of the efficacy, safety, and tolerability of 5, 10, and 20 mg/day vortioxetine in adults with major depressive disorder. Psychiatry Clin Neurosci. 2018 Feb;72(2):64-72. doi: 10.1111/pcn.12565. Epub 2017 Oct 3.
Results Reference
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Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
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